Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

April 2, 2014 updated by: Erchonia Corporation

Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.

The purpose of this study was to determine whether the application of low level laser light therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder pain of musculoskeletal origin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating. Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness. More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own. Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Location of pain is on the right and/or left side of the neck and/or shoulder and/or the back of the neck.
  • Etiology of pain is osteoarthritis/Degenerative Joint Disorder (DJD); chronic muscle spasms or cervical and thoracic spine sprain strain, determined according to subject medical history, medication use history, previous records review, physical examination of the cervical spine and shoulder.
  • Stage of injury is chronic, having prevailed for longer than 30 days.
  • Degree of Pain self-rating of 50 or greater on the 0-100 Visual Analog Scale (VAS).
  • 18-65 years.

Exclusion Criteria:

  • Stage of injury is acute, having prevailed for less than 30 days.
  • Known herniated disc injury.
  • Any other disease or condition that may cause or contribute to the chronic pain condition.
  • Presence of infection or open wound at the treatment areas.
  • Use of steroids or narcotics.
  • Use of over-the-counter (OTC) medication for the relief of pain within the 24-hour period prior to participating in the treatment phase of the study, or prescription medication for the relief of pain within the 48-hour period prior to participating in the treatment phase of the study.
  • pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo laser
inactive laser light
Device: Placebo laser
Inactive laser light
Active Comparator: Erchonia PL2000
The Erchonia PL2000 Laser emits 1 milliWatt (mW) of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
Device: Erchonia PL2000
The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
Other Names:
  • Erchonia PL5000
  • Erchonia EVRL Laser

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment
Time Frame: baseline and one day
Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.
baseline and one day
Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment
Time Frame: baseline and one day
Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.
baseline and one day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Range of Motion of the Neck and Shoulders
Time Frame: one day
one day
Muscle Trigger Points of the Cervical Spine
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erchonia Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory C Roche, DO
  • Principal Investigator: Douglas D Dedo, MD
  • Principal Investigator: Edward B Lack, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2001

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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